I did not ask you where you read the word "firewall" in the guidelines, I asked you if you knew what one was. You just cited a subsection having to do with external data and sponsor requests for interim protocol changes [Subsection 4.4.1.4]. You completely ignored all the subsection exceptions to access that I cited to you in my previous post on this matter.
For instance, let's go over section 6.5 and see where a "firewall" is recommended without using the word firewall.
Please pay special attention to the passages placed in bold.
6.5." Sponsor Access to Interim Data for Planning Purposes
Often, sponsors wish to have access to unblinded interim data for the purpose of planning product development, e.g., designing/initiating further trials or making decisions regarding production facilities. This interest is understandable, but such access is problematic for reasons already discussed. In general, sponsors are advised to avoid seeking information about unblinded interim data because of the significant possibility that they may wind up impairing trial management or even making the trial results uninterpretable by doing so. Further, plans or decisions based on statistically imprecise interim data may often be suboptimal. Where the sponsor nonetheless has a compelling need to review such information, certain approaches may lessen, although they do not eliminate, risks to the trial:
"….Identification of those sponsor employees with a critical "need-to-know" and restriction of such information to those individuals only.
Ensuring that individuals with access to the information avoid any subsequent role in the management of the trial and minimize interactions with others in that role.
Ensuring that individuals who have access to such information make every effort to avoid taking actions that will assist others in inferring what the information is.
Ensuring that reports of study findings describe any access to interim data by individuals involved with study management, and steps taken to prevent such access from potentially biasing the study results."
Now what would that fire-walled employee be allowed to do with that information? IMHO.
Section 6.5
"Often, sponsors wish to have access to unblinded interim data for the purpose of planning product development, e.g., designing/initiating further trials or making decisions regarding production facilities. " While this is "understandable" it is often "undesirable," however, if the sponsor has a "compelling need" they can use the firewall sections just mentioned to prevent problems. IMHO Another proactive step to avoid misstep is the following:
"Discussion of such an action with FDA in advance. This is particularly advisable when the sponsor intends to use the study in support of a licensing [Germany?] or marketing application."
Now how do you think NWBO is going to work with the FDA to make certain its licensing in Germany is properly handled. You got it, the PEI-FDA Commitment previously posted by Staccanni.
(Note: So the section you cited is protocol modification specific.)
AI
